FDA.reportPublic FDA data

Depth Gauge

Primary DI
08437006085182
Brand
Depth Gauge
Company
NEOS SURGERY SL
Model
SCI0000
Device description
DEPTH GAUGE
Published
2024-09-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
08437006085182PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08437006085182084370060851828437006085182

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
0935944726info@neosurgery.com

Regulatory Flags#

DUNS number
465890437
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08437006085458STERN FIXSC0102222024-09-04
08437006085465STERN FIXSC0103332024-09-04
08437006085489STERN FIXSC0105552024-09-04
08437006085212RetractorSCI03002024-09-04
08437006085434CutterSCI07002024-09-04
28437006085452STERN FIXSC0102222024-09-04
28437006085469STERN FIXSC0103332024-09-04
08437006085472STERN FIXSC0104442024-09-04
28437006085483STERN FIXSC0105552024-09-04
08437006085496ForcepsSCI05012024-09-04
08437006085441STERN FIXSC0101112024-09-01
28437006085445STERN FIXSC0101112024-09-01
08437006085076Cranial COVER “14 mm / 13 mm”FC0503002017-05-11
08437006085083Cranial COVER “10-12 mm”FC0504002017-05-11
18437006085042Cranial LOOPFC0500002015-11-08
18437006085066Cranial LOOP XLFC0502002016-02-04
48437006085043Cranial LOOPFC0500002015-11-08
18437006085059Cranial LOOP LFC0501002016-02-04
48437006085067Cranial LOOP XLFC0502002016-02-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841731133663REDEMPTION Beaming SystemVILEX LLCHTJ2026-11-03
03700569683030Newclip InstrumentsNEWCLIP TECHNICSHTJ2026-10-30
03700569683047Newclip InstrumentsNEWCLIP TECHNICSHTJ2026-10-30
03700569683054Newclip InstrumentsNEWCLIP TECHNICSHTJ2026-10-30
00842078137338MetaForeEXTREMITY MEDICAL, LLCHTJ2026-10-28
00190776435509MillenniumAvalign Technologies, Inc.HTJ2026-10-20
04719886915273U-Motion IIUNITED ORTHOPEDIC CORP.HTJ2026-10-15
10886982345455VOLTSynthes GmbHHTJ2026-09-25
00840606191609Overwatch PCFSPINAL ELEMENTS, INC.HTJ2026-07-31
03700569674250Newclip InstrumentsNEWCLIP TECHNICSHTJ2026-07-27
03700569674274Newclip InstrumentsNEWCLIP TECHNICSHTJ2026-07-27
00842188130311Tools - ScrewsTrimed, INC.HTJ2026-07-22
06974940307243endophixSuzhou Endophix Co., Ltd.HTJ2026-06-23
08809513720045SAEHAN Hydraulic Pinch GaugeSaehan CorporationHTJ2026-05-18
08809513720359SAEHAN Mechanical Pinch GaugeSaehan CorporationHTJ2026-05-18
08800322750001AnyPlus®GS Medical Co., Ltd.HTJ2026-04-21
00810112597486TriLEAPSynthes GmbHHTJ2026-02-10
10850070500484Cannulated Depth Guage CURVAFIX, INC.HTJ2025-10-22
00810135963404ImpactNVision Biomedical Technologies, Inc.HTJ2025-09-24
05055662971057ORTHO SOLUTIONS SUCCESSION AFN SYSTEMORTHO SOLUTIONS HOLDINGS LIMITEDHTJ2025-08-15
08800071006862Surgical InstrumentOSTEONIC CO.,Ltd.HTJ2025-06-24
08809539690667Surgical InstrumentOSTEONIC CO.,Ltd.HTJ2025-06-24
10840199512703Depth GaugeKOROS U.S.A., INC.HTJ2024-12-31
10840199513670Multi Level Black Belt Depth GaugeKOROS U.S.A., INC.HTJ2024-12-31
00810112597936MOTOBAND InstrumentsCROSSROADS EXTREMITY SYSTEMSHTJ2024-07-31
00810112592542TriLEAPSynthes GmbHHTJ2024-02-23
00810112592702TriLEAPSynthes GmbHHTJ2024-02-23
00810112592719TriLEAPSynthes GmbHHTJ2024-02-23
10885862573483EPICExactech, Inc.HTJ2024-01-08
B56251300MDG000G10WishBone Plate & Screw SystemWishbone Medical, Inc.HTJ2024-01-01