FDA.reportPublic FDA data

NA

Primary DI
10888551035224
Brand
NA
Company
STERILMED, INC.
Model
STR1608-2-11
Catalog number
1608-2-11
Device description
BUR STAINLESS STEEL ROUND MICRO 10 FLUTES
Published
2018-06-18
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GFFBUR, SURGICAL, GENERAL & PLASTIC SURGERY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GFFBur, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10888551035224PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088855103522410888551035224

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bur, single-useA sterile, rotary cutting device consisting of a shaft of high-grade steel and a cutting head of hard metal/material with fluting or cutting planes of various shapes at the working end and which is designed to fit into an appropriate powered handpiece that provides the rotation allowing the user to excavate/shape bone tissue during small and large bone surgery (e.g., maxillofacial, spinal, or orthopaedic). This is a single-use device.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

Phone, Email table
PhoneEmail
+1(888)541-0078customerservice@sterilmed.com
+1(888)541-0078sterilmedcs@its.jnj.com

Regulatory Flags#

DUNS number
175899459
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10888551045735Reprocessed SOUNDSTAR CRYSTAL™ Ultrasound Catheter For Use on GE SystemR11657485R116574852026-07-06
10888551045742Reprocessed AcuNav CRYSTAL™ Ultrasound Catheter For Use on GE SystemR11657484R116574842026-07-06
10888551045759Reprocessed AcuNav CRYSTAL™ Ultrasound Catheter For Use on Siemens SystemR11510825R115108252026-07-06
10888551045766Reprocessed SOUNDSTAR CRYSTAL™ Ultrasound Catheter For Use on Siemens SystemR11510826R115108262026-07-06
10888551001205NAMED5455SLMED5455SL2016-09-22
10888551004312NAMID7BA407BA402018-06-18
10888551004329NAMID7BA40D7BA40D2018-06-18
10888551017862NALIN5052-1865052-1862018-06-18
10888551045292NASYN03.312.090SYN03.312.0902019-11-15
10888551045308NASYN03.312.120SYN03.312.1202019-11-15
10888551045315NASYN394.88SYN394.882019-11-15
10888551045322NASYN03.312.680SYN03.312.6802019-11-15
10888551045339NASYN394.89SYN394.892019-11-15
10888551045346NASYN394.90SYN394.902019-11-15
10888551045353NASYN394.91SYN394.912019-11-15
10888551045360NASYN394.92SYN394.922019-11-15
10888551045377NASYN03.312.620SYN03.312.6202019-11-15
10888551045384NASYN03.312.650SYN03.312.6502019-11-15
10888551045391NASYN03.312.710SYN03.312.7102019-11-15
10888551045407NASYN03.312.740SYN03.312.7402019-11-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00817438028762N/AOmega Surgical Instruments IncGFF2026-10-05
14053613298343KOMET Surgical BurGebr. Brasseler GmbH & Co. KGGFF2026-09-30
14053613298350KOMET Surgical BurGebr. Brasseler GmbH & Co. KGGFF2026-09-30
14053613293133KOMET Surgical BurGebr. Brasseler GmbH & Co. KGGFF2026-09-25
05051471225985De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGFF2026-08-01
00817438028724N/AOmega Surgical Instruments IncGFF2026-07-24
00817438028755N/AOmega Surgical Instruments IncGFF2026-07-21
10080196377244MEDLINEMEDLINE INDUSTRIES, INC.GFF2025-01-29
10080196385560MEDLINEMEDLINE INDUSTRIES, INC.GFF2025-01-29
14053613001493KOMET Surgical BurGebr. Brasseler GmbH & Co. KGGFF2023-01-31
14053613001738KOMET Surgical BurGebr. Brasseler GmbH & Co. KGGFF2023-01-31
E226000108G11KOMET Surgical BurGebr. Brasseler GmbH & Co. KGGFF2023-01-31
E226000109G11KOMET Surgical BurGebr. Brasseler GmbH & Co. KGGFF2023-01-31
E226000106AL1KOMET Surgical BurGebr. Brasseler GmbH & Co. KGGFF2023-01-27
E226000104AL1KOMET Surgical BurGebr. Brasseler GmbH & Co. KGGFF2023-01-24
E226000104G11KOMET Surgical BurGebr. Brasseler GmbH & Co. KGGFF2023-01-24
10845854012581VORTEX, STERLINGConmed CorporationGFF2023-01-19
10845854012598VORTEX, STERLINGConmed CorporationGFF2023-01-19
10845854017791STERLINGConmed CorporationGFF2023-01-19
10845854029626STERLINGConmed CorporationGFF2023-01-19
10845854029671LIGHTNING, STERLINGConmed CorporationGFF2023-01-19
10845854040621ULTRATIGERConmed CorporationGFF2023-01-19
05051471027725De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGFF2022-11-29
05051471030152De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGFF2022-11-29
05051471089792De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGFF2022-11-29
05051471089808De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGFF2022-11-29
05051471089815De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGFF2022-11-29
05051471089839De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGFF2022-11-29
05051471089853De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGFF2022-11-29
05051471089877De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGFF2022-11-29