Simplebag

FDA UDI

Class II (US FDA UDI)

by Dannik LLC

Identity

Trade Name: SIMPLEBAG FDA UDI
Generic Name: Tissue extraction bag FDA UDI
Device Name: PMI SimpleBag 15 2XL Simple Specimen Retrieval Bag, 3000mL FDA UDI
Model / Reference: PNS3000 FDA UDI
Description: PMI SimpleBag 15 2XL Simple Specimen Retrieval Bag, 3000mL FDA UDI

Identifiers

Primary DI / UDI-DI: 10850013527585 FDA UDI
FDA Product Code: GCJ FDA UDI
GMDN Term: Tissue extraction bag FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 876.1500 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

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Tissue extraction bag

Simplebag by Dannik LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Tissue extraction bag.

Alexis® Contained Extraction System — APPLIED MEDICAL RESOURCES CORP. · Class II
SimplyStrong — Genicon · Class II
Monopolar posts long for handles — ORANGE SURGICAL INSTRUMENTS, LLC · Class II
DR. POYNTER MC — APPLIED MEDICAL RESOURCES CORP. · Class II
DR.BRIZENDINE LAP CHOLECYSTECTOMY — APPLIED MEDICAL RESOURCES CORP. · Class I
GeniStrong — Genicon · Class II
TOTAL 5mm SOLUTION KIT 11 — APPLIED MEDICAL RESOURCES CORP. · Class II
PARTNERS LC KIT 006 — APPLIED MEDICAL RESOURCES CORP. · Class II

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

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

Manufacturer

Manufacturer: Dannik LLC

Sources (1)

FDA UDI daa473a6-3363-4fe5-b485-02102cfbe1b1 33 fields · synced Jun 1, 2026