FDA.report

Bioseal Inc.

Primary DI
10630094777419
Brand
Bioseal Inc.
Company
BIOSEAL
Model
27-774S/20
Device description
Braun Uterine Tenaculum Forceps
Published
2023-12-28
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

Related Records

Product Codes

CodeName
KDCINSTRUMENT, SURGICAL, DISPOSABLE

Product Code Classifications

CodeDeviceSpecialtyClass
KDCInstrument, Surgical, DisposableGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10630094777419PackageGS120In Commercial Distribution
00630094777412PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1063009477741910630094777419
00630094777412006300947774126300947774120630094777412

GMDN Terms

TermDefinition
Uterine tenaculumA hand-held manual surgical instrument with hooks at the distal end used for grasping and/or manipulating uterine tissue during a surgical intervention or examination of the uterus and associated structures (e.g., cervix). It typically has a scissors-like, self-retaining design with ring handles and is made of high-grade stainless steel. It is available in various sizes. This is a reusable device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
186968939
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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10630094292240Bioseal Inc.32-922-4/202024-01-10
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10630094055111Bioseal Inc.551S/202024-01-29
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10630094061525Bioseal Inc.6152/502024-01-29
10630094064243Bioseal Inc.6424/1202024-01-29

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