FDA.reportPublic FDA data

Bioseal Inc.

Primary DI
00630094481029
Brand
Bioseal Inc.
Company
BIOSEAL
Model
DURA102/100
Device description
Duraholder 12.75" x 17.25"
Published
2025-05-29
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
true

Product Codes#

Code, Name table
CodeName
MDMInstrument, Manual, Surgical, General Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MDMInstrument, Manual, Surgical, General UseGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10630094481026PrimaryGS10
00630094481029Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1063009448102610630094481026
00630094481029006300944810296300944810290630094481029

GMDN Terms#

Term, Definition table
TermDefinition
Surgical instrument interim-placement holder, single-useA device intended to be used in the operating room (OR) by staff to safely hold a hand-held, manual, surgical instrument(s) [e.g., needle, scalpel, scissors, robotic system instrument hand-held remote controller] when not in use during surgery, to avoid damage to the instrument, maintain its sterility, and/or for temporary storage (e.g., to enable easy transfer/handling of the instrument at reduced risk of injury). It is available in various forms (e.g., rack, puncture cushion, telescopic tube, magnetic mat), and may be attached to a surgical drape; it is not a numbered tray and is not intended for counting of sharps. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
186968939
Device count
100
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
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00630094198514Bioseal Inc.19851NS/1002023-12-07
00630094171470Bioseal Inc.17147/012023-09-18
00630094017501Bioseal Inc.1750/502023-09-25
10630094481026Bioseal Inc.DURA102/1002025-05-29
10630094481231Bioseal Inc.DURA123/1002025-05-29
10630094483006Bioseal Inc.DURA300/1002025-05-29
10630094485055Bioseal Inc.DURA505/1002025-05-29
10630094485123Bioseal Inc.DURA512/1002025-05-29
10630094487028Bioseal Inc.DURA702/1002025-05-29
10630094487059Bioseal Inc.DURA705/1002025-05-29
10630094487301Bioseal Inc.DURA730/1002025-05-29
10630094489022Bioseal Inc.DURA902/1002025-05-29
00630094481234Bioseal Inc.DURA123/1002025-05-29
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

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Primary DI, Brand, Company table
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