Exact Medical Manufacturing, Inc.

FDA UDI

Class II (US FDA UDI)

by Exact Medical Manufacturing

Identity

Trade Name: Exact Medical Manufacturing, Inc. FDA UDI
Generic Name: Medical equipment/instrument drape, single-use FDA UDI
Device Name: Dome Bag 90cm - 35" FDA UDI
Model / Reference: E5317 FDA UDI
Description: Dome Bag 90cm - 35" FDA UDI

Identifiers

Catalog Number: E5317 FDA UDI
Primary DI / UDI-DI: 00816953021388 FDA UDI
FDA Product Code: KKX 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: Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

Yes

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Dome Bag 90cm - 35", a single-use, sterile, and hygienic medical instrument drape designed for General, Plastic Surgery procedures. This flexible polymer sheet/bag/sleeve is intended to form a protective water-resistant enclosure around equipment/instruments, protecting them from soiling and contamination while in or near a hygienic area. Its primary purpose is to serve as a barrier, not an attachment, making it suitable for implantable devices.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Exact Medical Manufacturing

Sources (1)

FDA UDI 07c7ed8e-bc19-47d1-9934-a4c384f44a6b 36 fields · synced Jul 18, 2026