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Dinamic OR Gerstner Double Wide Orange Cover Labeled A1-A8

FDA UDI

Class II (US FDA UDI)

by Flex Operating Room, Inc

Identity

Trade Name
Dinamic OR Gerstner Double Wide Orange Cover Labeled A1-A8 FDA UDI
Generic Name
Instrument/equipment drape, single-use, sterile FDA UDI
Model / Reference
2000A-B FDA UDI

Identifiers

Catalog Number
2000A-B FDA UDI
Primary DI / UDI-DI
00869653000221 FDA UDI
510(k) Number
K101598 FDA UDI
FDA Product Code
KKX FDA UDI
GMDN Term
Instrument/equipment drape, single-use, sterile 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

No

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Instrument/equipment drape, single-use, sterile

Dinamic OR Gerstner Double Wide Orange Cover Labeled A1-A8 by Flex Operating Room, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Instrument/equipment drape, single-use, sterile.

Cleared under the same submission

K101598 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Flex Operating Room, Inc

Sources (1)

  • FDA UDI bbd5ccd0-f59b-448e-be7f-2ac9e61ff428 35 fields · synced May 30, 2026