FDA.reportPublic FDA data

Medline

Primary DI
10884389180976
Brand
Medline
Company
MEDLINE INDUSTRIES, INC.
Model
MDS1192428
Catalog number
MDS1192428
Device description
"KERRISON, MICRO, 40 DEG UP, 12"" 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
10884389180976PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088438918097610884389180976

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
10197344227464MEDLINEDYNCCDS10TDYNCCDS10T2026-11-05
20197344020789MEDLINEDYND364958DYND3649582026-11-05
00197344154336MEDLINENON25511NON255112026-11-03
10197344220588MEDLINEMSC608ASGVMSC608ASGV2026-11-03
10198459763977MEDLINEURO195714URO1957142026-09-15
10198459809224MEDLINEVASC2005VASC20052026-11-03
10198459814969MEDLINEVASC2008VASC20082026-11-03
10198459815508MEDLINEVASC1794CVASC1794C2026-11-03
10653160394471MEDLINEDYNDV2774ADYNDV2774A2026-11-04
20888277636757MEDLINEMDTZ1068516AWMDTZ1068516AW2026-11-03
20080196921277GeminiGEM2140GEM21402016-10-14
10197344148462MEDLINERTDCIHCMGRTDCIHCMG2026-10-30
10197344148479MEDLINERTDCIHCMNRTDCIHCMN2026-10-30
10197344148486MEDLINERTDCIHCMPRTDCIHCMP2026-10-30
10197344148493MEDLINERTDCIHCMRRTDCIHCMR2026-10-30
10197344148509MEDLINERTDCIHCMYRTDCIHCMY2026-10-30
10197344148516MEDLINERTDCIHCMZRTDCIHCMZ2026-10-30
10197344148523MEDLINERTDCINCMBRTDCINCMB2026-10-30
10197344148530MEDLINERTDCINCMGRTDCINCMG2026-10-30
10197344148547MEDLINERTDCINCMNRTDCINCMN2026-10-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776439880MilleniumAvalign Technologies, Inc.HAE2026-11-05
00190776439897MilleniumAvalign Technologies, Inc.HAE2026-11-05
00190776440879MilleniumAvalign Technologies, Inc.HAE2026-11-05
00190776439835MilleniumAvalign Technologies, Inc.HAE2026-10-28
B382SD9228132210Surgical DirectSurgical Direct, Inc.HAE2026-10-20
B382SD9228132220Surgical DirectSurgical Direct, Inc.HAE2026-10-20
00840217900089Wiggins MedicalEBNER MEDICAL, LLCHAE2021-03-29
00840217900096Ace MedicalEBNER MEDICAL, LLCHAE2021-03-29
00840217900171Ace MedicalEBNER MEDICAL, LLCHAE2021-03-29
00840217900188Ace MedicalEBNER MEDICAL, LLCHAE2021-03-29
00840217900195Ace MedicalEBNER MEDICAL, LLCHAE2021-03-29
00840217900201Ace MedicalEBNER MEDICAL, LLCHAE2021-03-29
00840217900218Ace MedicalEBNER MEDICAL, LLCHAE2021-03-29
00840217900225Ace MedicalEBNER MEDICAL, LLCHAE2021-03-29
00840217900232Ace MedicalEBNER MEDICAL, LLCHAE2021-03-29
00840217900249Ace MedicalEBNER MEDICAL, LLCHAE2021-03-29
00840217900256Ace MedicalEBNER MEDICAL, LLCHAE2021-03-29
00840217900263Ace MedicalEBNER MEDICAL, LLCHAE2021-03-29
00840217900270Ace MedicalEBNER MEDICAL, LLCHAE2021-03-29
00840217900287Ace MedicalEBNER MEDICAL, LLCHAE2021-03-29
00840217900294Ace MedicalEBNER MEDICAL, LLCHAE2021-03-29
00840217900300Ace MedicalEBNER MEDICAL, LLCHAE2021-03-29
00840217900317Ace MedicalEBNER MEDICAL, LLCHAE2021-03-29
00840217900324Ace MedicalEBNER MEDICAL, LLCHAE2021-03-29
00840217900331Ace MedicalEBNER MEDICAL, LLCHAE2021-03-29
00840217900348Ace MedicalEBNER MEDICAL, LLCHAE2021-03-29
00840217900355Ace MedicalEBNER MEDICAL, LLCHAE2021-03-29
00840217900362Ace MedicalEBNER MEDICAL, LLCHAE2021-03-29
00840217900379Ace MedicalEBNER MEDICAL, LLCHAE2021-03-29
00840217900386Ace MedicalEBNER MEDICAL, LLCHAE2021-03-29