FDA.reportPublic FDA data

Steribite

Primary DI
00850003512129
Brand
Steribite
Company
Steribite, LLC
Model
SB70854-1
Device description
Disposable Kerrison 40d UP, 8" 4mm
Published
2026-08-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HAERongeur, Manual

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HAERongeur, ManualNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K180949000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K180949000SteribiteRjr Surgical, Inc.2018-11-08HAE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850003512150PackageGS15In Commercial Distribution
00850003512129PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850003512150008500035121508500035121500850003512150
00850003512129008500035121298500035121290850003512129

GMDN Terms#

Term, Definition table
TermDefinition
Spinal rongeurA hand-held manual surgical instrument with sharp, scoop-shaped jaws designed for cutting tough tissues (intervertebral disk) or bone, through a cutting/biting action, during open spinal surgery (e.g., laminectomy, discectomy). It is typically made of metal and designed to withstand the forces required to bite over tough tissue. It is not intended for endoscopic access. This is a reusable device.

Regulatory Flags#

DUNS number
118544718
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850003512006SteribiteSB70851-12026-08-27
00850003512044SteribiteSB70852-12026-08-27
00850003512082SteribiteSB70853-12026-08-27
00850003512167SteribiteSB70855-12026-08-27
00850003512235SteribiteSB71155-12026-08-27
00850003512273SteribiteSB71154-12026-08-27
00850003512310SteribiteSB71153-12026-08-27
00850003512358SteribiteSB71152-12026-08-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776424008MillenniumAvalign Technologies, Inc.HAE2026-08-27
00190776424084MillenniumAvalign Technologies, Inc.HAE2026-08-27
00850003512006SteribiteSteribite, LLCHAE2026-08-27
00850003512044SteribiteSteribite, LLCHAE2026-08-27
00850003512082SteribiteSteribite, LLCHAE2026-08-27
00850003512167SteribiteSteribite, LLCHAE2026-08-27
00850003512235SteribiteSteribite, LLCHAE2026-08-27
00850003512273SteribiteSteribite, LLCHAE2026-08-27
00850003512310SteribiteSteribite, LLCHAE2026-08-27
00850003512358SteribiteSteribite, LLCHAE2026-08-27
04250325495029VitalitecVitalitec International Medizintechnik GmbHHAE2026-08-27
04250325495036VitalitecVitalitec International Medizintechnik GmbHHAE2026-08-27
04250325495050VitalitecVitalitec International Medizintechnik GmbHHAE2026-08-27
04255968300884VitalitecVitalitec International Medizintechnik GmbHHAE2026-08-27
04255968300891VitalitecVitalitec International Medizintechnik GmbHHAE2026-08-27
04255968300914VitalitecVitalitec International Medizintechnik GmbHHAE2026-08-27
04255968300921VitalitecVitalitec International Medizintechnik GmbHHAE2026-08-27
04255968300938VitalitecVitalitec International Medizintechnik GmbHHAE2026-08-27
04255968300945VitalitecVitalitec International Medizintechnik GmbHHAE2026-08-27
04255968300952VitalitecVitalitec International Medizintechnik GmbHHAE2026-08-27
04255968300969VitalitecVitalitec International Medizintechnik GmbHHAE2026-08-27
04255968300976VitalitecVitalitec International Medizintechnik GmbHHAE2026-08-27
04255968300983VitalitecVitalitec International Medizintechnik GmbHHAE2026-08-27
04255968300990VitalitecVitalitec International Medizintechnik GmbHHAE2026-08-27
04255968301003VitalitecVitalitec International Medizintechnik GmbHHAE2026-08-27
04255968301010VitalitecVitalitec International Medizintechnik GmbHHAE2026-08-27
04255968301027VitalitecVitalitec International Medizintechnik GmbHHAE2026-08-27
04255968301034VitalitecVitalitec International Medizintechnik GmbHHAE2026-08-27
04255968301041VitalitecVitalitec International Medizintechnik GmbHHAE2026-08-27
04255968301058VitalitecVitalitec International Medizintechnik GmbHHAE2026-08-27