SurgiFish

FDA UDI

Class I (US FDA UDI)

by Greer Medical, Inc.

Identity

Trade Name: SurgiFish FDA UDI
Generic Name: Viscera retention paddle FDA UDI
Device Name: SurgiFish Viscera Retainer FDA UDI
Model / Reference: 4001 Pouch FDA UDI
Description: SurgiFish Viscera Retainer FDA UDI

Identifiers

Catalog Number: 4001 FDA UDI
Primary DI / UDI-DI: 00854373007094 FDA UDI
FDA Product Code: GCZ FDA UDI
GMDN Term: Viscera retention paddle FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.4800 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Length — 13.75 Inch FDA UDI
Width — 5.375 Inch FDA UDI

Category: Viscera retention paddle

SurgiFish by Greer Medical, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Viscera retention paddle.

LapPakOR — THE O R COMPANY PTY LTD · Class I
Breast Implant Protector — ADEPT MED INTERNATIONAL INC · Class I
Viscera Retainer, Fish — ADEPT MED INTERNATIONAL INC · Class I
Viscera Retainer, Fish — ADEPT MED INTERNATIONAL INC · Class I
Viscera Retainer, Fish — ADEPT MED INTERNATIONAL INC · Class I
Viscera Retainer, Fish — ADEPT MED INTERNATIONAL INC · Class I
Discectomy Set — SPINEOLOGY INC. · Class I
Viscera Retainer, Fish — ADEPT MED INTERNATIONAL INC · Class I

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 I	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Greer Medical, Inc.

Sources (1)

FDA UDI ad0ced93-f395-4456-99dd-c8e3346f39c0 37 fields · synced Jun 1, 2026