FDA.reportPublic FDA data

SCHANZ PIN FASTENER INSTRUMENT TRAY

Primary DI
00816950029967
Brand
SCHANZ PIN FASTENER INSTRUMENT TRAY
Company
SMV SCIENTIFIC LLC
Model
303-9002
Catalog number
303-9002
Device description
SCHANZ PIN FASTENER INSTRUMENT TRAY
Published
2022-02-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LRPTray, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LRPTray, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816950029967PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816950029967008169500299678169500299670816950029967

GMDN Terms#

Term, Definition table
TermDefinition
Surgical instrument/implant rackA device designed as a small case, typically with a hinged lid that can be closed to protect the contents (i.e., surgical instruments and/or implantable devices such as plates or screws), and an integral rest(s) with grooves or notches in the upper edge so that the contents can be securely placed, protected, and organized. The lid or rest may be set at an angle to facilitate instrument/implant access during surgical procedures or sterilization. The device is typically be made of stainless steel or a suitable plastic material so that it can be sterilized. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
1-800-969-0639quality@osteocentric.com

Regulatory Flags#

DUNS number
089645059
Device count
1
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
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
008100743000014.0 x 12mm Screw Super Fastener, ST340-2012340-20122023-06-12
008100743000184.0 x 14mm Screw Super Fastener, ST340-2014340-20142023-06-12
008100743000254.0 x 16mm Screw Super Fastener, ST340-2016340-20162023-06-12
008100743000324.0 x 18mm Screw Super Fastener, ST340-2018340-20182023-06-12
008100743000494.0 x 20mm Screw Super Fastener, ST340-2020340-20202023-06-12
008100743000564.0 x 22mm Screw Super Fastener, ST340-2022340-20222023-06-12
008100743000634.0 x 24mm Screw Super Fastener, ST340-2024340-20242023-06-12
008100743000704.0 x 26mm Screw Super Fastener, ST340-2026340-20262023-06-12
008100743000874.0 x 28mm Screw Super Fastener, ST340-2028340-20282023-06-12
008100743000944.0 x 30mm Screw Super Fastener, ST340-2030340-20302023-06-12
008100743001004.0 x 32mm Screw Super Fastener, ST340-2032340-20322023-06-12
008100743001174.0 x 34mm Screw Super Fastener, ST340-2034340-20342023-06-12
008100743001244.0 x 36mm Screw Super Fastener, ST340-2036340-20362023-06-12
008100743001314.0 x 38mm Screw Super Fastener, ST340-2038340-20382023-06-12
008100743001484.0 x 40mm Screw Super Fastener, ST340-2040340-20402023-06-12
008100743001554.0 x 42mm Screw Super Fastener, ST340-2042340-20422023-06-12
008100743001624.0 x 44mm Screw Super Fastener, ST340-2044340-20442023-06-12
008100743001794.0 x 46mm Screw Super Fastener, ST340-2046340-20462023-06-12
008100743001864.0 x 48mm Screw Super Fastener, ST340-2048340-20482023-06-12
008100743001934.0 x 50mm Screw Super Fastener, ST340-2050340-20502023-06-12

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