FDA.reportPublic FDA data

PremierPro

Primary DI
00818566017529
Brand
PremierPro
Company
PRESTIGE AMERITECH, LTD.
Model
3601
Catalog number
3601
Device description
Amniotic Hook, Sterile
Published
2020-08-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HHFRemover, Intrauterine Device, Contraceptive, Hook-Type

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HHFRemover, Intrauterine Device, Contraceptive, Hook-TypeObstetrics/Gynecology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10818566017526PackageGS1100In Commercial Distribution
20818566017523PackageGS16In Commercial Distribution
00818566017529PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081856601752610818566017526
2081856601752320818566017523
00818566017529008185660175298185660175290818566017529

GMDN Terms#

Term, Definition table
TermDefinition
Intrauterine device removal hook, single-useA sterile, hand-held manual instrument intended to be used by a physician for the extraction of an intrauterine device (IUD). The proximal end forms a handle which may vary in shape and which tapers toward the distal end to form a hook. It is typically made of high-grade stainless steel. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
1-855-531-7699info@s2s-global.com

Regulatory Flags#

DUNS number
199692794
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00852212003801ProGear7410E32026-04-21
00852212003788PrestigePro24512026-03-27
00852212003795PrestigePro24532026-03-27
00818566016454PremierPro24512016-07-15
00818566019783PremierPro24532020-04-28
20818566017479PremierPro531153112020-07-15
20818566017486PremierPro531253122020-07-15
00811220030001PremierPro6604PP6604PP2020-09-08
00811220030018PremierPro6605PP6605PP2020-09-08
00811220030032PremierPro24922020-04-28
00811220030049PremierPro881788172020-08-29
00811220030056PremierPro881888182020-08-29
00811220030063PremierPro881988192020-08-29
00811220030278PremierPro635563552020-08-02
00811220030308PremierPro500150012020-06-26
00811220030315PremierPro500250022020-06-26
00811220030322PremierPro500350032020-06-26
00811220030339PremierPro500450042020-06-26
00811220030346PremierPro500550052020-06-26
00811220030360PremierPro Lancet755275522018-08-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05010058078482InstrapacROBINSON HEALTHCARE LIMITEDHHF2025-05-21
05010058178489InstrapacROBINSON HEALTHCARE LIMITEDHHF2025-05-21
00194613032456MSI Precision Specialty InstrumentsMed Saver, Inc.HHF2025-03-21
00887482040751Symmetry SurgicalASPEN SURGICAL PRODUCTS, INC.HHF2024-09-05
00840183500092BR Surgical, LLCBR Surgical, LLCHHF2024-02-29
00840183500870BR Surgical, LLCBR Surgical, LLCHHF2024-02-29
00840183502263BR Surgical, LLCBR Surgical, LLCHHF2024-02-29
GYNX292001GynexGYNEX CORPORATIONHHF2023-12-26
GYNX293001GynexGYNEX CORPORATIONHHF2023-12-26
GYNX298501GynexGYNEX CORPORATIONHHF2023-12-26
GYNX291000GynexGYNEX CORPORATIONHHF2023-12-26
GYNX292000GynexGYNEX CORPORATIONHHF2023-12-26
GYNX293500GynexGYNEX CORPORATIONHHF2023-12-26
GYNX295500GynexGYNEX CORPORATIONHHF2023-12-26
GYNX298000GynexGYNEX CORPORATIONHHF2023-12-26
GYNX298500GynexGYNEX CORPORATIONHHF2023-12-26
GYNX299000GynexGYNEX CORPORATIONHHF2023-12-26
G586OB96417600Novo SurgicalNOVO SURGICAL, INC.HHF2023-12-18
G586OB96417670Novo SurgicalNOVO SURGICAL, INC.HHF2023-12-18
G586OB96417680Novo SurgicalNOVO SURGICAL, INC.HHF2023-12-18
GYNX290100GynexGYNEX CORPORATIONHHF2023-12-13
GYNX290200GynexGYNEX CORPORATIONHHF2023-12-13
05010058070240InstrapacROBINSON HEALTHCARE LIMITEDHHF2023-08-08
05010058170247InstrapacROBINSON HEALTHCARE LIMITEDHHF2023-08-08
00190776250737AvalignAvalign Technologies, Inc.HHF2023-06-23
00842962162101HNM MEDICALHNM STAINLESS, LLC.HHF2023-05-27
00842962162118HNM MEDICALHNM STAINLESS, LLC.HHF2023-05-27
00842962129036HNM MEDICALHNM STAINLESS, LLC.HHF2023-03-30
00842962129043HNM MEDICALHNM STAINLESS, LLC.HHF2023-03-30
14026704792174PILLINGTELEFLEX INCORPORATEDHHF2022-12-08