FDA.reportPublic FDA data

PremierPro

Primary DI
10818566017526
Brand
PremierPro
Company
SVS LLC
Model
3601
Catalog number
3601
Device description
Amniotic Hook, Sterile
Published
2020-08-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
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.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
831375089
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00811220035495PremierPro882088202024-10-28
00811220035518PremierPro882188212024-10-28
10811220035430PremierProD5061D50612024-03-08
10811220035447PremierProD5062D50622024-03-08
10811220035454PremierProD5063D50632024-03-08
10811220035461PremierProD5064D50642024-03-08
10811220035478PremierProD5065D50652024-03-08
00811220035143PremierProFL1003DFL1003D2024-02-14
00811220035174PremierProFL1005DFL1005D2024-02-14
00811220035099PremierProFL1010DFL1010D2024-02-14
00811220035112PremierProFL1010SFFL1010SF2024-02-14
00811220034412PremierPro™31T1417531T141752022-12-19
00811220034443PremierPro™31T1617731T161772022-12-19
00811220034474PremierPro™31T1811631T181162022-12-19
00811220034504PremierPro™31T1818831T181882022-12-19
00811220034535PremierPro™31T2011631T201162022-12-19
00811220034566PremierPro™31T2010031T201002022-12-19
00811220034597PremierPro™31T2018831T201882022-12-19
00811220034627PremierPro™31T2210031T221002022-12-19
00811220034658PremierPro™31T2407531T240752022-12-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776423988MillenniumAvalign Technologies, Inc.HHF2026-08-27
B382SD915598220Surgical DirectSurgical Direct, Inc.HHF2026-07-28
B382SD915599320Surgical DirectSurgical Direct, Inc.HHF2026-07-28
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