Repack Surgical Enterprises, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What Repack Surgical Enterprises, Inc. makes
Repack Surgical Enterprises, Inc. manufactures sterile surgical packs, including major drapes, basic drapes, gowns, and towels, designed for use in surgical procedures.
These products are classified as Class II medical devices and are listed under the FDA’s 510(k) pathway. The company is based in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Repak Surgical Packs Ref K903908
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Repack Surgical Enterprises, Inc. have in the registry?
The registry currently lists 2 devices for Repack Surgical Enterprises, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Repack Surgical Enterprises, Inc.'s devices?
Among its 2 most recently registered devices, Repack Surgical Enterprises, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Repack Surgical Enterprises, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Repack Surgical Enterprises, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Repack Surgical Enterprises, Inc. in the registry?
The most recently registered devices listed for Repack Surgical Enterprises, Inc. include REPAK SURGICAL PACK (GOWN, TOWEL, MAJOR, DRAPE, BASIC) and REPAK SURGICAL PACKS.