FDA.reportPublic FDA data

"Sterile Drape for ""SCOUT ARM"""

Primary DI
04260462743853
Brand
"Sterile Drape for ""SCOUT ARM"""
Company
Pemax Kunststoff GmbH
Model
12935.BUY0549
Device description
sterile Monitor and Boards Drape
Published
2025-03-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PUIDrape, Surgical, Exempt

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PUIDrape, Surgical, ExemptGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04260462743877PackageGS11In Commercial Distribution
04260462743853PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260462743877042604627438774260462743877
04260462743853042604627438534260462743853

GMDN Terms#

Term, Definition table
TermDefinition
Medical equipment/instrument drape, single-useA flexible polymer sheet/bag/sleeve designed to form a protective water-resistant enclosure around a piece of medical equipment/instrument (e.g., C-arm, surgical laser/camera/microscope, examination table/chair) and/or components (e.g., cables, tubes, headrest). It is intended as a hygienic barrier to protect the equipment/instrument from soiling and/or contamination when used inside, or within the vicinity of, a hygienic area; it may have patient contact, however it is not intended to be introduced into a body cavity (noninvasive). It is neither a dedicated handle cover, device cap nor an ultrasound transducer cover. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature-10 Degrees Celsius35 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+4974415204900info@pemax.de

Regulatory Flags#

DUNS number
341672714
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04260462743914"Steile Drape for ""Surgical Arm"""12935.BUY05482025-03-18
04260462743945"Steile Drape for ""CONTROL SCREEN"""12935.BUY05462025-03-18
04260462743877Sterile Drape for "SCOUT ARM"12935.BUY05492025-03-18
04260462743907"Steile Drape for ""Cart"""12935.BUY08872025-03-18
04260462743938Steile Drape for "Surgical Arm"12935.BUY05482025-03-18
04260462743969Steile Drape for "CONTROL SCREEN"12935.BUY05462025-03-18
04260462740357Sterile cover for RoboticScope AMP made of LDPE film 750 x 2100 x 0.050 mm12741.1236412741.123642024-06-05
04260462740524HMD cover set, consisting of 2 lens protective caps made of PP, color white12741.1236512741.123652024-06-05
04260462741279PEMICLIP-C-arm sterile cover set, frame cover w. 6 clips PC2SD-Siemens div./oranPC2-SD-3PC2-SD-32024-06-05
04260462742160Sterile cover for RoboticScope ArcView made of LDPE film 750 x 2100 x 0.050 mm12741.1387312741.138732024-06-05
04260462742405PEMICLIP - C-arm sterile cover set, widened frame cover with 6 clips PC3-SCSA-3 PC3-SCSA-3PC3-SCSA-32024-06-05
04260462742467PEMIDrape - C-arm sterile cover, metal temple cover blue line, Art.Nr. SP-CS-SD-SP-CS-SD-3SP-CS-SD-32024-06-05
04260462742528PEMIDrape - C-arm sterile cover set, metal temple cover blue line, Art.Nr. SP-CASP-CA-3SP-CA-32024-06-05
04260462742917"Smart Control Sterile Cover for Remote Control VB10 ""VB10-SC"""VB10-SCVB10-SC2024-06-05
04260462743006PEMICLIP - C-arm sterile cover set, widened frame cover with 6 clips PC3-VB10-3PC3-VB10-3PC3-VB10-32024-06-05
04260462743037"Sterile Cover for Remote Control Unit Drape Set ""VB10-RC"""VB10-RCVB10-RC2024-06-05
04260462742689Sterile Disposable Button Cannula, 100 mm lengthKK100L21SKK100L21S2024-06-05
04260462742702Sterile Disposable Button Cannula, 70 mm lengthKK70L150SKK70L150S2024-06-05
04260462742740Sterile Disposable Button Cannulas, 70 mm lengthKK70L50SKK70L50S2024-06-05
04260462742764Sterile Disposable Button Cannulas, 70 mm lengthKK70L21SKK70L21S2024-06-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
16931918100876AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-06-04
16931918102450AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-06-04
16931918104201AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-06-04
16931918104416AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-06-04
16931918104645AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-06-04
16931918104843AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-06-04
16931918104935AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-06-04
16931918105239AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-06-04
16931918106977AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-06-04
16931918107400AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-06-04
16931918107929AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-06-04
16931918108261AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-06-04
16931918109640AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-06-04
16931918109855AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-06-04
16931918109879AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-06-04
16931918117102AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-06-04
16931918139449AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-06-04
16931918179179AllesetGRI Medical & Electronic Technology Co., Ltd.PUI2026-06-04
30680651424465HalyardO&M HALYARD, INC.PUI2026-06-02
50192253071595CONVERTORSCardinal Health 200, LLCPUI2026-06-02
50192253071601CONVERTORSCardinal Health 200, LLCPUI2026-06-02
50192253071618CONVERTORSCardinal Health 200, LLCPUI2026-06-02
50192253071625CONVERTORSCardinal Health 200, LLCPUI2026-06-02
00748426121861OLYMPUSMicrotek Medical LLCPUI2026-05-28
07466532979338Moon SurgicalDAS Medical International SRLPUI2026-05-28
08681756013401PergoPERGO MEDIKAL VE ILAC SANAYI ANONIM SIRKETIPUI2025-12-26
08682952400545PergoPERGO MEDIKAL VE ILAC SANAYI ANONIM SIRKETIPUI2025-12-26
10809160479148HalyardAVID MEDICAL, INC.PUI2025-07-09
10080196073306MEDLINEMEDLINE INDUSTRIES, INC.PUI2025-06-19
10809160469972HalyardAVID MEDICAL, INC.PUI2025-06-12