FDA.reportPublic FDA data

Brain Depressor

Primary DI
00192896102781
Brand
Brain Depressor
Company
SONTEC INSTRUMENTS, INC.
Model
412-787
Device description
Cushing Brain Depressor Double-Ended
Published
2020-06-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GAFSPATULA, SURGICAL, GENERAL & PLASTIC SURGERY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GAFSpatula, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00192896102781PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00192896102781001928961027811928961027810192896102781

GMDN Terms#

Term, Definition table
TermDefinition
Vessel depressorA hand-held manual surgical instrument designed to displace tissue to facilitate examination of the surrounding area during vessel surgery. It is typically a double-ended device, that can be of various sizes and shapes (e.g., flat, curved, spoon-shaped, or fenestrated) with the working ends slightly angled to improve tissue manipulation and visibility. It is usually made of high-grade stainless steel. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length6.75Inch

Sterilization Methods#

Method table
Method
"[""Dry Heat Sterilization"", ""Moist Heat or Steam Sterilization""]"
Dry Heat Sterilization;Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)821-7496info@sontecinstruments.com

Regulatory Flags#

DUNS number
040729840
Device count
1
Premarket exempt
true
Lot or batch
true
No natural rubber latex
true
Sterilization required before use
true

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00192896123526Rochester Carmalt Forceps1100-150LQ1100-150LQ2026-06-24
00192896123533Rochester Carmalt Forceps1100-152LQ1100-152LQ2026-06-24
00192896123540Green Retractor207-298207-2982026-06-24
00192896103603ROCHESTER CARMALT FORCEPS1100-151Q1100-151Q2020-07-23
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00192896038141SONTEC-MICHELE TREPHINE419-395419-3952018-09-11
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00192896038165SONTEC-MICHELE TREPHINE419-397419-3972018-09-11
00192896038172SONTEC-MICHELE TREPHINE419-398419-3982018-09-11
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