FDA.report

Bioseal Inc.

Primary DI
10630094257751
Brand
Bioseal Inc.
Company
BIOSEAL
Model
25-775B/20
Device description
Fletcher Cervix Holding Forceps
Published
2023-12-26
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
10630094257751PackageGS120In Commercial Distribution
00630094257754PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1063009425775110630094257751
00630094257754006300942577546300942577540630094257754

GMDN Terms

TermDefinition
Manual expandable cervical dilatorA forceps-like surgical instrument designed to manually dilate the cervical canal after its insertion through the cervical os. It is typically constructed with two pivoted handles and opposing blunted blades that expand outward when the handles are manually squeezed, and possibly locked, dilating the cervical canal. This process is used to allow the passage of a curette or other instruments into the uterus. 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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00630094481029Bioseal Inc.DURA102/1002025-05-29
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00630094483009Bioseal Inc.DURA300/1002025-05-29
00630094485058Bioseal Inc.DURA505/1002025-05-29
00630094485126Bioseal Inc.DURA512/1002025-05-29
00630094487021Bioseal Inc.DURA702/1002025-05-29
00630094487052Bioseal Inc.DURA705/1002025-05-29
00630094487304Bioseal Inc.DURA730/1002025-05-29
00630094489025Bioseal Inc.DURA902/1002025-05-29
00630094480503Bioseal Inc.DURA050/1002025-05-28
10630094292240Bioseal Inc.32-922-4/202024-01-10
10630094335404Bioseal Inc.33-540/202024-01-10
10630094055111Bioseal Inc.551S/202024-01-29
10630094055135Bioseal Inc.551L/202024-01-29
10630094055142Bioseal Inc.551M/202024-01-29
10630094055197Bioseal Inc.551R/202024-01-29
10630094061501Bioseal Inc.6150/252024-01-29
10630094061518Bioseal Inc.6151/252024-01-29
10630094061525Bioseal Inc.6152/502024-01-29
10630094064243Bioseal Inc.6424/1202024-01-29

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