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Sterile cover for RoboticScope ArcView made of LDPE film 750 x 2100 x 0.050 mm

FDA UDI

Class II (US FDA UDI)

by Pemax Kunststoff GmbH

Identity

Trade Name
Sterile cover for RoboticScope ArcView made of LDPE film 750 x 2100 x 0.050 mm FDA UDI
Generic Name
Medical equipment/instrument drape, single-use FDA UDI
Device Name
Sterile cover for RoboticScope ArcView made of LDPE film 750 x 2100 x 0.050 mm FDA UDI
Model / Reference
12741.13873 FDA UDI
Description
Sterile cover for RoboticScope ArcView made of LDPE film 750 x 2100 x 0.050 mm FDA UDI

Identifiers

Catalog Number
12741.13873 FDA UDI
Primary DI / UDI-DI
04260462742160 FDA UDI
FDA Product Code
PUI FDA UDI
GMDN Term
Medical equipment/instrument drape, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4370 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Medical equipment/instrument drape, single-use

Sterile cover for RoboticScope ArcView made of LDPE film 750 x 2100 x 0.050 mm by Pemax Kunststoff GmbH — Class II — FDA UDI — listed in FDA GUDID

Similar devices

Also classified as Medical equipment/instrument drape, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Sources (1)

  • FDA UDI 8a7bfec7-5304-43a1-8116-332716a90dc5 36 fields · synced May 30, 2026