FDA.reportPublic FDA data

Medline

Primary DI
10884389184288
Brand
Medline
Company
MEDLINE INDUSTRIES, INC.
Model
MDS2055924C
Catalog number
MDS2055924C
Device description
"KERRISON, O/U, COAT, QUIK CLEAN, 9"",2MM"
Published
2022-01-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HAERONGEUR, MANUAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HAERongeur, ManualNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K081651000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K081651000INSTRUMED RONGEURInstrumed International, Inc.2008-08-08HAE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10884389184288PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088438918428810884389184288

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-5463service@medline.com

Regulatory Flags#

DUNS number
025460908
Device count
1
DM exempt
true
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10080196320899MEDLINEMDS30310MDS303102026-09-25
10080196321407MEDLINEMDS30605MDS306052026-09-25
10080196321414MEDLINEMDS30607MDS306072026-09-25
10080196321438MEDLINEMDS30803MDS308032026-09-25
10080196321452MEDLINEMDS30805MDS308052026-09-25
10080196321469MEDLINEMDS30806MDS308062026-09-25
10080196321476MEDLINEMDS30807MDS308072026-09-25
10080196321483MEDLINEMDS30808MDS308082026-09-25
10080196321490MEDLINEMDS30809MDS308092026-09-25
10198459754210MEDLINEVASC1970VASC19702026-09-25
10198459754524MEDLINEVASC1971VASC19712026-09-25
10198459755699MEDLINEVASC1959VASC19592026-09-25
10198459755705MEDLINEVASC1962VASC19622026-09-25
10198459758287MEDLINEVASC1974VASC19742026-09-25
10198459758294MEDLINEVASC1975VASC19752026-09-25
10198459759291MEDLINEVASC1976VASC19762026-09-25
10198459760846MEDLINEVASC1977VASC19772026-09-25
10198459761850MEDLINEVASC1978VASC19782026-09-25
10198459766336MEDLINEVASC1979VASC19792026-09-25
10198459771224MEDLINEVASC1980VASC19802026-09-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00724995311759V. MuellerSTERIS Deutschland GmbHHAE2026-09-25
00724995311766V. MuellerSTERIS Deutschland GmbHHAE2026-09-25
00724995311865V. MuellerSTERIS Deutschland GmbHHAE2026-09-25
00724995311872V. MuellerSTERIS Deutschland GmbHHAE2026-09-25
00724995311889V. MuellerSTERIS Deutschland GmbHHAE2026-09-25
00724995311964V. MuellerSTERIS Deutschland GmbHHAE2026-09-25
00724995311971V. MuellerSTERIS Deutschland GmbHHAE2026-09-25
00724995311988V. MuellerSTERIS Deutschland GmbHHAE2026-09-25
00724995311995V. MuellerSTERIS Deutschland GmbHHAE2026-09-25
00724995312008V. MuellerSTERIS Deutschland GmbHHAE2026-09-25
00724995312015V. MuellerSTERIS Deutschland GmbHHAE2026-09-25
00724995312077V. MuellerSTERIS Deutschland GmbHHAE2026-09-25
00724995312084V. MuellerSTERIS Deutschland GmbHHAE2026-09-25
00724995312091V. MuellerSTERIS Deutschland GmbHHAE2026-09-25
00724995312107V. MuellerSTERIS Deutschland GmbHHAE2026-09-25
00190776432331MillenniumAvalign Technologies, Inc.HAE2026-09-24
04250325493537VitalitecVitalitec International Medizintechnik GmbHHAE2026-09-22
04255968301713VitalitecVitalitec International Medizintechnik GmbHHAE2026-09-22
04255968301720VitalitecVitalitec International Medizintechnik GmbHHAE2026-09-22
04255968301737VitalitecVitalitec International Medizintechnik GmbHHAE2026-09-22
04255968301744VitalitecVitalitec International Medizintechnik GmbHHAE2026-09-22
04255968301751VitalitecVitalitec International Medizintechnik GmbHHAE2026-09-22
04255968301836VitalitecVitalitec International Medizintechnik GmbHHAE2026-09-22
04255968301843VitalitecVitalitec International Medizintechnik GmbHHAE2026-09-22
04255968301850VitalitecVitalitec International Medizintechnik GmbHHAE2026-09-22
04255968301867VitalitecVitalitec International Medizintechnik GmbHHAE2026-09-22
04255968301874VitalitecVitalitec International Medizintechnik GmbHHAE2026-09-22
04255968301959VitalitecVitalitec International Medizintechnik GmbHHAE2026-09-22
04255968301966VitalitecVitalitec International Medizintechnik GmbHHAE2026-09-22
04255968301973VitalitecVitalitec International Medizintechnik GmbHHAE2026-09-22