FDA.reportPublic FDA data

Symmetry Berke-Jaeger

Primary DI
00887482107089
Brand
Symmetry Berke-Jaeger
Company
ASPEN SURGICAL PRODUCTS, INC.
Model
60-1070E
Catalog number
60-1070E
Device description
Symmetry® Plate, Berke-Jaeger Lid, Ebonized
Published
2022-09-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
00887482107089PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887482107089008874821070898874821070890887482107089

GMDN Terms#

Term, Definition table
TermDefinition
Sterilization/disinfection container, reusableA receptacle designed to hold wrapped and/or unwrapped medical/dental devices in a chemical washer/disinfector and/or sterilizer during the washing/disinfection and/or sterilization cycle(s). It may be designed as a tray to allow full or partial immersion of the devices in a liquid disinfectant, or as an enclosed box to prevent contamination once the sterilization process is finished. The container may also be used for transport and storage of the processed devices, and may have features such as an expiry date label, breathing filter, built-in slots or inserts to hold instruments, and stacking capabilities. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1 888-364-7004customerservice@symmetrysurgical.com

Regulatory Flags#

DUNS number
027680821
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841785102714Symmetry Olsen20-1040I20-1040I2016-09-09
00841785102769Symmetry Olsen20-106020-10602016-09-06
00841785102776Symmetry Olsen20-1060I20-1060I2016-09-06
00841785102899Symmetry Olsen20-108020-10802016-09-06
00841785102905Symmetry Olsen20-1080I20-1080I2016-09-06
00841785102950Symmetry Olsen20-108220-10822016-09-06
00841785102967Symmetry Olsen20-1082I20-1082I2016-09-06
00841785102974Symmetry Olsen20-1082IMT20-1082IMT2016-09-07
00841785103025Symmetry Olsen20-109020-10902016-09-06
00841785103032Symmetry Olsen20-1090I20-1090I2016-09-06
00841785103049Symmetry Olsen20-1090IMT20-1090IMT2016-09-07
00841785103162Symmetry Olsen20-1162I20-1162I2016-09-06
00841785103285Symmetry Olsen20-1190I20-1190I2016-09-06
00841785103667Symmetry Olsen20-1325I20-1325I2016-09-08
00841785103674Symmetry Olsen20-1325IMT20-1325IMT2016-09-08
00841785103735Symmetry Olsen20-1330I20-1330I2016-09-08
00841785103742Symmetry Olsen20-1330IMT20-1330IMT2016-09-09
00841785103803Symmetry Olsen20-1340I20-1340I2016-09-06
00841785103865Symmetry Olsen20-1350I20-1350I2016-09-06
00841785103988Symmetry Olsen20-1360I20-1360I2016-09-06

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