FDA.reportPublic FDA data

Sierra

Primary DI
10889981094263
Brand
Sierra
Company
SEASPINE ORTHOPEDICS CORPORATION
Model
95-0113
Catalog number
95-0113
Device description
Depth Gauge
Published
2016-05-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HTJGAUGE, DEPTH

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTJGauge, DepthOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10889981094263PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088998109426310889981094263

GMDN Terms#

Term, Definition table
TermDefinition
Surgical depth gauge, reusableA surgical instrument designed to measure the depth of a recess, usually to measure the depth of holes being drilled in bone so that the surgeon can determine the length of the bone screw to be used. It may take two forms: 1) a device with a moveable (sliding) centrepiece (a prong), the tip of which is inserted into the recess to read from a scale; 2) a circular disc with a central hole which is clipped to a drill bit so that the device slides up as the drill bit is advanced. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(760)727-8399custsvcspine@seaspine.com

Regulatory Flags#

DUNS number
079840876
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
10889981137472Shoreline ACS86-001186-00112016-09-30
10889981125820Newport Complex MIS64-956564-95652026-03-03
10889981125851Newport Complex MIS64-959064-95902026-03-03
10889981130084Newport Complex MIS64-750564-75052026-03-03
10889981135331Newport Complex MIS64-552564-55252026-03-03
10889981135386Newport Complex MIS64-555564-55552026-03-03
10889981135393Newport Complex MIS64-556064-55602026-03-03
10889981135522Newport Complex MIS64-655064-65502026-03-03
10889981135553Newport Complex MIS64-656564-65652026-03-03
10889981135584Newport Complex MIS64-658564-65852026-03-03
10889981135591Newport Complex MIS64-659064-65902026-03-03
10889981135867Newport Complex MIS64-754564-75452026-03-03
10889981135997Newport Complex MIS64-851064-85102026-03-03
10889981136017Newport Complex MIS64-858564-85852026-03-03
10889981136079Newport Complex MIS64-957564-95752026-03-03
10889981136086Newport Complex MIS64-958564-95852026-03-03
10889981145668NewPort™65-474565-47452026-03-03
10889981145699NewPort™65-476065-47602026-03-03
10889981145750NewPort™65-555065-55502026-03-03
10889981145866NewPort™65-650065-65002026-03-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00199150076192Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HTJ2026-05-23
08809945895076EXULT Surgical InstrumentCorentec Co., LtdHTJ2026-03-23
00810111225649Depth GageTreace Medical Concepts, Inc.HTJ2026-03-19
10885862661449N/AExactech, Inc.HTJ2026-03-19
00840124525450Depth GaugeFUSION ORTHOPEDICS, LLCHTJ2026-03-06
08809945895021EXULT Surgical InstrumentCorentec Co., LtdHTJ2026-02-20
08809945895038EXULT Surgical InstrumentCorentec Co., LtdHTJ2026-02-20
08809945895045EXULT Surgical InstrumentCorentec Co., LtdHTJ2026-02-20
08809945895052EXULT Surgical InstrumentCorentec Co., LtdHTJ2026-02-20
08809945895069EXULT Surgical InstrumentCorentec Co., LtdHTJ2026-02-20
08809945895083EXULT Surgical InstrumentCorentec Co., LtdHTJ2026-02-20
08809945895090EXULT Surgical InstrumentCorentec Co., LtdHTJ2026-02-20
08809945895106EXULT Surgical InstrumentCorentec Co., LtdHTJ2026-02-20
08809945895113EXULT Surgical InstrumentCorentec Co., LtdHTJ2026-02-20
00810112597486TriLeap Lower Extremity Anatomic Plating SystemCROSSROADS EXTREMITY SYSTEMSHTJ2026-02-10
06438394001534Activa InstrumentBioretec OyHTJ2026-01-30
06438394001541Activa InstrumentBioretec OyHTJ2026-01-30
06438394005266Activa InstrumentBioretec OyHTJ2026-01-28
00840124525191DynaBridgeFUSION ORTHOPEDICS, LLCHTJ2026-01-19
00840124525207DynaBridgeFUSION ORTHOPEDICS, LLCHTJ2026-01-19
00840124525214DynaBridgeFUSION ORTHOPEDICS, LLCHTJ2026-01-19
00841731135520Redemption VILEX LLCHTJ2026-01-13
00841506137520ProteanSKELETAL DYNAMICS L.L.C.HTJ2025-12-01
00841506138077ProteanSKELETAL DYNAMICS L.L.C.HTJ2025-12-01
00841506138947Proximal Humerus Plating SystemSKELETAL DYNAMICS L.L.C.HTJ2025-12-01
00841506145945Proximal Humerus Plating SystemSKELETAL DYNAMICS L.L.C.HTJ2025-12-01
04262494462580N/ADoppkon GmbH & Co. KGHTJ2025-12-01
08056693027987INTRAUMA SURGICAL INSTRUMENTINTRAUMA SPAHTJ2025-11-27
08800068959690LOSPA Surgical InstrumentsCorentec Co., LtdHTJ2025-11-25
08800068959706LOSPA Surgical InstrumentsCorentec Co., LtdHTJ2025-11-25