FDA.reportPublic FDA data

Smart Control Sterile Cover for Remote Control VB10 "VB10-SC"

Primary DI
04260462743129
Brand
Smart Control Sterile Cover for Remote Control VB10 "VB10-SC"
Company
Pemax Kunststoff GmbH
Model
VB10-SC
Catalog number
VB10-SC
Device description
Smart Control Sterile Cover for Remote Control VB10 "VB10-SC"
Published
2024-06-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
04260462743129PackageGS14In Commercial Distribution
04260462742917PrimaryGS10
04260462743112Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260462743129042604627431294260462743129
04260462742917042604627429174260462742917
04260462743112042604627431124260462743112

GMDN Terms#

Term, Definition table
TermDefinition
Medical equipment drape, single-useA flexible polymer sheet/bag/sleeve designed to form a protective water-resistant enclosure around a piece of medical equipment (e.g., C-arm, surgical laser/camera/microscope, examination table/chair) and/or equipment components (e.g., cables, tubes, headrest). It is intended as a hygienic barrier to protect the contents from soiling and contamination when used in the vicinity of, or entered into, a hygienic area. 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
Storage Environment Temperature-10 Degrees Celsius35 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
341672714
Device count
50
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04260462743853"Sterile Drape for ""SCOUT ARM"""12935.BUY05492025-03-18
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

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Primary DI, Brand, Company table
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30680651501302HalyardO&M HALYARD, INC.PUI2026-06-08
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