FDA.report

BR Surgical, LLC

Primary DI
00840183500870
Brand
BR Surgical, LLC
Company
BR Surgical, LLC
Model
BR70-63148
Catalog number
BR70-63148
Device description
Simple IUD Hook, malleable, 10"
Published
2024-02-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
HHFRemover, Intrauterine Device, Contraceptive, Hook-Type

Product Code Classifications

CodeDeviceSpecialtyClass
HHFRemover, Intrauterine Device, Contraceptive, Hook-TypeObstetrics/Gynecology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840183500870PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840183500870008401835008708401835008700840183500870

GMDN Terms

TermDefinition
Intrauterine device removal hook, reusableA 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 reusable device.

Sterilization Methods

Method
Ethylene Oxide;Moist Heat or Steam Sterilization

Contacts

PhoneEmail
1-904-642-1366customerservice@brsurgical.com

Regulatory Flags

DUNS number
134781207
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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00840183530846BR Surgical, LLCBR99-29455BR99-294552025-09-03
00840183530853BR Surgical, LLCBR99-29456BR99-294562025-09-03
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G586OB96417680Novo SurgicalNOVO SURGICAL, INC.HHF2023-12-18
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GYNX290200GynexGYNEX CORPORATIONHHF2023-12-13
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00190776250737AvalignAVALIGN TECHNOLOGIES, INC.HHF2023-06-23
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54026704792172PILLINGTELEFLEX INCORPORATEDHHF2022-12-08
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00842331146190Novo Surgical Inc. NOVO SURGICAL, INC.HHF2022-11-11
00840306806780Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.HHF2022-11-08
00840306806797Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.HHF2022-11-07
00888937019667Double IUD ExtractorCoopersurgical, Inc.HHF2022-10-30