FDA.reportPublic FDA data

OTOSILK™ Graft Dressing

Primary DI
EBESOT46010
Brand
OTOSILK™ Graft Dressing
Company
Boston Medical Products, Inc.
Model
OT-4601
Catalog number
OT-4601
Device description
Size: 100 x 150 mm; Type: Nylon
Published
2015-09-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NABGauze/Sponge,Nonresorbable For External Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NABGauze / Sponge,Nonresorbable For External UseGeneral, Plastic Surgery1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K964534000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K964534000OTOSILK OTOLOGICAL GRAFT DRESSINGBoston Medical Products, Inc.1997-04-09NAD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EBESOT46011PackageHIBCC10In Commercial Distribution
EBESOT46010PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Wound-nonadherent dressing, permeable, non-antimicrobialA wound covering typically in the form of a porous material (e.g., a fine mesh) impregnated/coated with a substance (e.g., petrolatum, silicone) or made of a material that prevents adherence to the wound bed, thereby decreasing the potential for trauma to the wound and surrounding skin upon removal; it does not contain an antimicrobial agent. Its pores permit the drainage of exudates from, and application of medication to, the wound. It may be used with other wound-care products for chronic and postoperative wounds, burns, skin graft fixation/cultured-cell carrier, cuts, or abrasions; it is neither a dedicated burn dressing nor gauze. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length100Millimeter
Width150Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep away from sunlight
Special Storage Condition, Specify00Keep dry

Contacts#

Phone, Email table
PhoneEmail
1-800-433-2674info@bosmed.com

Regulatory Flags#

DUNS number
131855157
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

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14063107103084Montgomery® Safe-T-Tube™4600094600092024-09-28
14063107103091Montgomery® Safe-T-Tube™460009R460009R2024-09-28
14063107103107Montgomery® Safe-T-Tube™4600104600102024-09-28
14063107103114Montgomery® Safe-T-Tube™460010R460010R2024-09-28
14063107103121Montgomery® Safe-T-Tube™4600114600112024-09-28
14063107103138Montgomery® Safe-T-Tube™460011R460011R2024-09-28
14063107103145Montgomery® Safe-T-Tube™4600124600122024-09-28
14063107103152Montgomery® Safe-T-Tube™460012R460012R2024-09-28

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