FDA.reportPublic FDA data

Protean

Primary DI
00841506138077
Brand
Protean
Company
SKELETAL DYNAMICS L.L.C.
Model
Depth Gauge, PROTEAN, Mini
Catalog number
DPGA-PRT-02
Device description
Depth Gauge, PROTEAN, Mini
Published
2025-12-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
00841506138077PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841506138077008415061380778415061380770841506138077

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(305)596-7585feedback@skeletaldynamics.com

Regulatory Flags#

DUNS number
869056148
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
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841506141442Distal Elbow Plating SystemFreeFix, Proximal Ulna Plate, 7 Slot, RightPUPF-7SR2026-03-05
00841506141459Distal Elbow Plating SystemFreeFix, Proximal Ulna Plate, 7 Slot, LeftPUPF-7SL2026-03-05
00841506141466Distal Elbow Plating SystemFreeFix, Proximal Ulna Plate, 8 Slot, RightPUPF-8SR2026-03-05
00841506141473Distal Elbow Plating SystemFreeFix, Proximal Ulna Plate, 8 Slot, LeftPUPF-8SL2026-03-05
00841506141480Distal Elbow Plating SystemFreeFix, Proximal Ulna Plate, 8 Slot Plus, RightPUPF-8SPR2026-03-05
00841506141497Distal Elbow Plating SystemFreeFix, Proximal Ulna Plate, 8 Slot Plus, LeftPUPF-8SPL2026-03-05
00841506117621GeminusRadial Hook Plate Guide, RightGMN-HPG-RR2026-01-21
00841506117638GeminusRadial Hook Plate Guide, LeftGMN-HPG-RL2026-01-21
00841506117645GeminusUlnar Hook Plate GuideGMN-HPG-UB2026-01-21
00841506117652GeminusGEMINUS Hook Plate, Radial, RightGMN-HP-RR2026-01-21
00841506117669GeminusGEMINUS Hook Plate, Radial, LeftGMN-HP-RL2026-01-21
00841506142333GeminusButtress Button, 6.35mm Round, 0.6mm x 152mmBB-RND-012026-01-21
00841506142340GeminusWire Guide, Tapered, 0.9mm x 152mmWG-ST-091522026-01-21
00841506142364GeminusWire Cutter, Small, AngledINST-WC-SM2026-01-21
00841506142708GeminusMarginal Fragment ModuleGMN-MF-MOD2026-01-21
00841506112763ProteanCMC Osteotomy Cutting GuidePRT-CTG-CMC2025-12-01
00841506113050ProteanPROTEAN Fragment Plate, CMCPRT-MFP-CMC2025-12-01
00841506136028ProteanScrew, Variable Angle Locking, 2.5mm x 6mm, CoCrVAL-25060-CC2025-12-01
00841506136035ProteanScrew, Variable Angle Locking, 2.5mm x 7mm, CoCrVAL-25070-CC2025-12-01
00841506136042ProteanScrew, Variable Angle Locking, 2.5mm x 8mm, CoCrVAL-25080-CC2025-12-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
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
08800068959713LOSPA Surgical InstrumentsCorentec Co., LtdHTJ2025-11-25