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Helen Keller CYSTO PACK

FDA UDI

by Packroom Llc

Identity

Trade Name
Helen Keller CYSTO PACK FDA UDI
Generic Name
General surgical procedure kit, non-medicated, single-use FDA UDI
Device Name
Helen Keller CYSTO PACK FDA UDI
Model / Reference
HK170 FDA UDI
Description
Helen Keller CYSTO PACK FDA UDI

Identifiers

Primary DI / UDI-DI
00817395022643 FDA UDI
GMDN Term
General surgical procedure kit, non-medicated, single-use FDA UDI

Classification

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

No

FDA UDI

Convenience Kit

Yes

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

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: General surgical procedure kit, non-medicated, single-use

Helen Keller CYSTO PACK by Packroom Llc — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as General surgical procedure kit, non-medicated, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Packroom Llc

Sources (1)

  • FDA UDI ede9a48d-56dd-4b6e-9fed-337880a898f0 33 fields · synced Jun 1, 2026