FDA.reportPublic FDA data

NATIONAL HOSPITAL PACKAGING

Primary DI
00817213022930
Brand
NATIONAL HOSPITAL PACKAGING
Company
Surgi-Pak, Inc.
Model
8172NS
Catalog number
8172NS
Device description
VAGINAL PACKING GAUZE, 2IN X 100YDS, 1/PKG, X-RAY DETECTABLE, NSTRL
Published
2023-08-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GDYGauze/Sponge, Internal, X-Ray Detectable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GDYGauze/Sponge, Internal, X-Ray DetectableGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817213022947PackageGS11In Commercial Distribution
00817213022930PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817213022947008172130229478172130229470817213022947
00817213022930008172130229308172130229300817213022930

GMDN Terms#

Term, Definition table
TermDefinition
Radiopaque woven surgical spongeA non-medicated device made from woven gauze (e.g., cotton, cellulose) primarily intended to be used inside the body, on a surgical incision or applied to internal organs or structures to control bleeding, absorb fluid, or protect organs or structures from abrasion, drying, or contamination during a procedure; also referred to as a laparotomy sponge, it may also be used for prepping the patient. It contains an x-ray detectable marker [e.g., a thread or strand(s)] to help detect gossypiboma (sponge left inside patient). This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
6269683335orders@nhpsurgipak.com

Regulatory Flags#

DUNS number
152736971
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817213020615NATIONAL HOSPITAL PACKAGING14-01214-0122022-12-05
00817213020639NATIONAL HOSPITAL PACKAGING14-01514-0152022-12-05
00817213020646NATIONAL HOSPITAL PACKAGING14-00514-0052022-12-05
00817213020653NATIONAL HOSPITAL PACKAGING14-01314-0132022-12-05
00817213020660NATIONAL HOSPITAL PACKAGING14-01414-0142022-12-05
00817213021322NATIONAL HOSPITAL PACKAGING34-00434-0042022-12-06
00817213022817NATIONAL HOSPITAL PACKAGING37-42037-4202022-12-06
00817213020608NATIONAL HOSPITAL PACKAGING14-00114-0012022-12-05
00817213020622NATIONAL HOSPITAL PACKAGING14-00414-0042022-12-05
00817213021162NATIONAL HOSPITAL PACKAGING26-002R26-002R2022-12-06
00817213021605NATIONAL HOSPITAL PACKAGING26-001R26-001R2022-12-06
00817213020165NATIONAL HOSPITAL PACKAGING11-00211-0022022-12-05
00817213020172NATIONAL HOSPITAL PACKAGING11-00311-0032022-12-05
00817213020189NATIONAL HOSPITAL PACKAGING11-00411-0042022-12-05
00817213020202NATIONAL HOSPITAL PACKAGING11-01211-0122022-12-05
00817213020219NATIONAL HOSPITAL PACKAGING11-01311-0132022-12-05
00817213020226NATIONAL HOSPITAL PACKAGING11-01411-0142022-12-05
00817213020233NATIONAL HOSPITAL PACKAGING11-01611-0162022-12-05
00817213020257NATIONAL HOSPITAL PACKAGING11-03311-0332022-12-05
00817213020288NATIONAL HOSPITAL PACKAGING11-03611-0362022-12-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00199536924000BluelineTransparent Supply Solutions Ltd.GDY2026-08-07
00199536924024BluelineTransparent Supply Solutions Ltd.GDY2026-08-07
00199536924031BluelineTransparent Supply Solutions Ltd.GDY2026-08-07
00199536924055BluelineTransparent Supply Solutions Ltd.GDY2026-08-07
10198956239692CARDINAL HEALTHCardinal Health 200, LLCGDY2025-11-28
00850049994866SynterventionZien Medical Technologies, LLCGDY2025-09-26
00850049994873SynterventionZien Medical Technologies, LLCGDY2025-09-26
00850049994880SynterventionZien Medical Technologies, LLCGDY2025-09-26
00850049994897SynterventionZien Medical Technologies, LLCGDY2025-09-26
00850049994903SynterventionZien Medical Technologies, LLCGDY2025-09-26
00850049994910SynterventionZien Medical Technologies, LLCGDY2025-09-26
00850049994927SynterventionZien Medical Technologies, LLCGDY2025-09-26
00850049994934SynterventionZien Medical Technologies, LLCGDY2025-09-26
00850049994941SynterventionZien Medical Technologies, LLCGDY2025-09-26
00850049994958SynterventionZien Medical Technologies, LLCGDY2025-09-26
00850049994965SynterventionZien Medical Technologies, LLCGDY2025-09-26
00850049994972SynterventionZien Medical Technologies, LLCGDY2025-09-26
00850049994996SynterventionZien Medical Technologies, LLCGDY2025-09-23
00850049994989SynterventionZien Medical Technologies, LLCGDY2025-09-22
07613327465853SurgiCount Safety-SpongeSTRYKER CORPORATIONGDY2025-09-03
10080196717811MEDLINEMEDLINE INDUSTRIES, INC.GDY2025-04-25
10810178830005Tally Surgical SolutionTally Surgical, Inc.GDY2025-02-18
10197106760994CARDINAL HEALTHCardinal Health 200, LLCGDY2025-01-29
10080196031313MEDLINEMEDLINE INDUSTRIES, INC.GDY2025-01-16
10080196743926MEDLINEMEDLINE INDUSTRIES, INC.GDY2024-10-15
10326053119504Regard™Resource Optimization & Innovation, L.L.C.GDY2023-08-09
10326053119511Regard™Resource Optimization & Innovation, L.L.C.GDY2023-08-09
10326053119528Regard™Resource Optimization & Innovation, L.L.C.GDY2023-08-09
10326053119535Regard™Resource Optimization & Innovation, L.L.C.GDY2023-08-09
10326053119542Regard™Resource Optimization & Innovation, L.L.C.GDY2023-08-09