FDA.reportPublic FDA data

Streamline OCT

Primary DI
00840311237111
Brand
Streamline OCT
Company
Xtant Medical Holdings, Inc.
Model
23-DEPTH-GAGE
Device description
DEPTH GAGE
Published
2023-10-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LXHOrthopedic manual surgical instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840311237111PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840311237111008403112371118403112371110840311237111

GMDN Terms#

Term, Definition table
TermDefinition
Surgical depth gauge, single-useA surgical instrument designed to measure the depth of a recess, usually to measure the depth of holes being drilled in bone to determine the length of the bone screw to be used. It may take the form of: 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; or 3) a cylindrical rod with markings. This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(844)894-7752customerservice@surgalign.com

Regulatory Flags#

DUNS number
081224143
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00849777014144Vesuvius Flowable DBM, 1cc4104-K5010DP2026-09-14
00849777014151Vesuvius Flowable DBM, 2.5cc4104-K5025DP2026-09-14
00849777014168Vesuvius Flowable DBM, 5cc4104-K5050DP2026-09-14
00849777014175Vesuvius Flowable DBM, 10cc4104-K5100DP2026-09-14
00849777014182Vesuvius Flowable DBM, 0.5cc4104-K5005DP2026-09-14
00849777014052Union DBM, 1cc11-0001-0012026-06-24
00849777014069Union DBM, 2.5cc11-0001-0022026-06-24
00849777014076Union DBM, 5cc11-0001-0052026-06-24
00849777014083Union DBM, 10cc11-0001-0102026-06-24
00849777012232DBM Putty Plus 2.5cc - JarMM34252023-01-11
00849777012256DBM Putty Plus 10.0cc - JarMM35002023-01-11
00849777013475OsteoPore Plus DBM Putty 2.5cc SyringeSC-5202-DBM2025-02-19
00849777013482OsteoPore Plus DBM Putty 5.0cc SyringeSC-5205-DBM2025-02-19
00849777013499OsteoPore Plus DBM Putty 10.0cc SyringeSC-5210-DBM2025-02-19
00849777013444OsteoPore Plus DBM Putty 2.5cc Syringe359425-SC2025-01-31
00849777013451OsteoPore Plus DBM Putty 5.0cc Syringe359450-SC2025-01-31
00849777013468OsteoPore Plus DBM Putty 10.0cc Syringe359500-SC2025-01-31
00849777012911Hero DBM Putty, 1.0cc01001-0012024-09-17
00849777012928Hero DBM Putty, 2.5cc01001-0022024-09-17
00849777012935Hero DBM Putty, 5.0cc01001-0052024-09-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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00190446960393DYNANAIL HELIXMedshape, Inc.LXH2026-10-09
00198506095771ELMED INCORPORATEDELMED INCORPORATEDLXH2026-10-09
00198506095788ELMED INCORPORATEDELMED INCORPORATEDLXH2026-10-09
00810155330781Tigon MedicalTigon Medical LLCLXH2026-10-09
08056711926636Orthopaedic Manual Surgical InstrumentsCITIEFFE SRLLXH2026-10-09
08809986489753LnK Spinal Instrument SystemL&K BIOMED CO. ,LTD.LXH2026-10-08
08809986489760LnK Spinal Instrument SystemL&K BIOMED CO. ,LTD.LXH2026-10-08
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08809986489784LnK Spinal Instrument SystemL&K BIOMED CO. ,LTD.LXH2026-10-08
08809986489791LnK Spinal Instrument SystemL&K BIOMED CO. ,LTD.LXH2026-10-08
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00840493441658LUX Expandable Interbody SystemXENIX MEDICAL LLCLXH2026-10-05
00840493441696RIVA Pedicle Screw SystemXENIX MEDICAL LLCLXH2026-10-05
00840493442020Xenix Medical Universal HandleXENIX MEDICAL LLCLXH2026-10-05
00840493442037Xenix Medical Universal HandleXENIX MEDICAL LLCLXH2026-10-05
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