FDA.reportPublic FDA data

PEMICLIP-C-arm sterile cover set, frame cover w. 6 clips PC2SD-Siemens div./oran

Primary DI
04260462741279
Brand
PEMICLIP-C-arm sterile cover set, frame cover w. 6 clips PC2SD-Siemens div./oran
Company
Pemax Kunststoff GmbH
Model
PC2-SD-3
Catalog number
PC2-SD-3
Device description
PEMICLIP-C-arm sterile cover set, frame cover w. 6 clips PC2SD-Siemens div./orange line
Published
2024-06-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

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
04260462741255PackageGS14In Commercial Distribution
04260462741279PrimaryGS10
04260462741262Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260462741255042604627412554260462741255
04260462741279042604627412794260462741279
04260462741262042604627412624260462741262

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
Storage Environment Temperature-10 Degrees Celsius35 Degrees Celsius

Regulatory Flags#

DUNS number
341672714
Device count
5
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

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
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

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