FDA.report

SourceMark

Primary DI
10813799000109
Brand
SourceMark
Company
SOURCEMARK, LLC.
Model
M0912
Published
2020-07-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
BSRStylet, Tracheal Tube

Product Code Classifications

CodeDeviceSpecialtyClass
BSRStylet, Tracheal TubeAnesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10813799000109PackageGS120In Commercial Distribution
20813799000113PackageGS120In Commercial Distribution
00813799000096PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1081379900010910813799000109
2081379900011320813799000113
00813799000096008137990000968137990000960813799000096

GMDN Terms

TermDefinition
Artificial airway stylet, single-useA sterile, long, stiffening wire/rod designed for insertion within the lumen of an artificial airway tube (e.g., endotracheal tube, bronchial tube) to stiffen and/or maintain the shape of the tube to facilitate introduction (intubation). It is designed to be slightly shorter than the tube to avoid damage to the airway during passage, and is withdrawn after intubation has been completed. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
121225812
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
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00813799002748SourceMark CV3WF2022-02-24
00813799002861SourceMark CV1002022-02-24
00813799002878SourceMark CVST12022-02-24
00813799003349SourceMark SLH022020-12-04
10813799003377SourceMark SLMAC102020-12-04
10813799003407SourceMark SLMAC202020-12-04
10813799003438SourceMark SLMAC302020-12-04
10813799003490SourceMark SLMAC402020-12-04
10813799003520SourceMark SLMIL002020-12-04
10813799003551SourceMark SLMIL02020-12-04
10813799003582SourceMark SLMIL102020-12-04
10813799003612SourceMark SLMIL202020-12-04
10813799003643SourceMark SLMIL302020-12-04
10813799003674SourceMark SLMIL402020-12-04
10813799006774SourceMark SMC400-MP-M2020-12-04
10813799006804SourceMark SMC400-P-M2020-12-04
10813799003735SourceMark CV2BL2020-07-21
10813799003766SourceMark CV3BL2020-07-21
10813799003797SourceMark CV4BL2020-07-21
00813799003813SourceMark CV3LH2020-07-21

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
20889483033309SunMedSUNMED, LLCBSR2026-02-18
20889483033316SunMedSUNMED, LLCBSR2026-02-18
20889483033323SunMedSUNMED, LLCBSR2026-02-18
10848530094673AnesthesiaSUNSET HEALTHCARE SOLUTIONS, INC.BSR2025-12-10
10848530094680AnesthesiaSUNSET HEALTHCARE SOLUTIONS, INC.BSR2025-12-10
10848530094697AnesthesiaSUNSET HEALTHCARE SOLUTIONS, INC.BSR2025-12-10
10848530094703AnesthesiaSUNSET HEALTHCARE SOLUTIONS, INC.BSR2025-12-10
04250105630435Ambu® SureSight TM Stylet; smallVBM Medizintechnik GmbHBSR2025-07-02
14250105630449Ambu® SureSight TM Stylet; mediumVBM Medizintechnik GmbHBSR2025-07-02
14250105630456Ambu® SureSight TM Stylet; largeVBM Medizintechnik GmbHBSR2025-07-02
10860004198861Stylet – Tracheal Tube/ Bougie CatheterGMMI SDN. BHD.BSR2025-05-23
05030267167678UNIVERSAL STYLET BOUGIE (USB) WITHOUT SACHET OF LUBRICANTIntersurgical IncorporatedBSR2025-03-14
16936881166676Intubating StyletWell Lead Medical Co.,LtdBSR2025-02-06
16936881166683Intubating StyletWell Lead Medical Co.,LtdBSR2025-02-06
16936881166690Intubating StyletWell Lead Medical Co.,LtdBSR2025-02-06
16936881166706Intubating StyletWell Lead Medical Co.,LtdBSR2025-02-06
06936881166716Intubating StyletWell Lead Medical Co.,LtdBSR2025-02-06
16936881166720Intubating StyletWell Lead Medical Co.,LtdBSR2025-02-06
16944932773414Intubating StyletWell Lead Medical Co.,LtdBSR2025-02-06
16944932773438Intubating StyletWell Lead Medical Co.,LtdBSR2025-02-06
16944932773445Intubating StyletWell Lead Medical Co.,LtdBSR2025-02-06
16944932773452Intubating StyletWell Lead Medical Co.,LtdBSR2025-02-06
16944932773483Intubating StyletWell Lead Medical Co.,LtdBSR2025-02-06
06970283489394UE Intubation StyletZhejiang UE Medical CorpBSR2024-12-17
06970283489424UE Intubation StyletZhejiang UE Medical CorpBSR2024-12-17
00850059297070Runnels Steerable Introducer™ #2.5 Oral/NasalThrough The Cords, LLCBSR2024-10-23
00850059297018Runnels Steerable Introducer™ #5 NasalThrough The Cords, LLCBSR2024-10-22
00850059297049Runnels Steerable Introducer™ #2 Oral/NasalThrough The Cords, LLCBSR2024-10-22
00850059297100Runnels Steerable Introducer™ #3 Oral/NasalThrough The Cords, LLCBSR2024-10-22
00850059297131Runnels Steerable Introducer™ DLT (35F/37F)Through The Cords, LLCBSR2024-10-22