FDA.reportPublic FDA data

Elite

Primary DI
00810633022030
Brand
Elite
Company
Biomedical Enterprises, Inc.
Model
EL-DTH
Device description
BME ELITE H-SERIES DRILLING TEMPLATE KIT
Published
2017-02-15
Public version status
Update
Distribution status
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
KDDKit, Surgical Instrument, Disposable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KDDKit, Surgical Instrument, DisposableGeneral, Plastic Surgery1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K150125000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K150125000Elite Nitinol Fixation SystemBiomedical Enterprises, Inc.2015-05-11JDR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810633022030PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810633022030008106330220308106330220300810633022030

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic surgical procedure kit, non-medicated, single-useA collection of various sterile orthopaedic surgical instruments, dressings, and other materials intended to be used to perform an orthopaedic surgical procedure, however the kit is not dedicated to orthopaedic implantation. It does not contain pharmaceuticals. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Lumen/Inner Diameter3Millimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
210-881-0064aknight@bme-tx.com

Regulatory Flags#

DUNS number
792619009
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810633020005HammerLockHLXM2015-10-24
00810633020012HammerLockHLDIP2015-10-24
00810633020029HammerLockHLXL2015-10-24
00810633020036HammerLockHLXLA2015-10-24
00810633020043HammerLockHLXMA2015-10-24
00810633020050HammerLockHLXP2015-10-24
00810633020067HammerLockHLXS2015-10-24
00810633020074HammerLockHLXSA2015-10-24
00810633021361HammerLockHLXM2015-10-24
00810633021378HammerLockHLDIP2015-10-24
00810633021385HammerLockHLXL2015-10-24
00810633021392HammerLockHLXLA2015-10-24
00810633020173SpeedSE-15152015-10-24
00810633020180SpeedSE-18152015-10-24
00810633020197SpeedSE-18182015-10-24
00810633020203SpeedSE-1818152015-10-24
00810633020210SpeedSE-20152015-10-24
00810633020227SpeedSE-20202015-10-24
00810633020234SpeedSE-25202015-10-24
00810633020258SpeedLS-09072015-10-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800071700500TIGER GUARD PLUSKims Med Co.,Ltd.KDD2025-11-28
10080196042777MEDLINEMEDLINE INDUSTRIES, INC.KDD2025-06-02
08800071700111Tiger GuardKims Med Co.,Ltd.KDD2024-07-30
10193489951936Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KDD2024-07-29
08906039319729OSSEOUS Myringotomy Kit-StandardEON MEDITECH PRIVATE LIMITEDKDD2024-07-04
08906039319736OSSEOUS Myringotomy Kit-Pediatric EON MEDITECH PRIVATE LIMITEDKDD2024-07-04
10192253065442Aero-MedAERO-MED, LLCKDD2024-03-11
00811870037979Manus Medical, LLCManus Medical, LLCKDD2024-02-06
10195327271626Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KDD2023-06-13
10195327271770Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KDD2023-06-13
10195327273293Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KDD2023-06-13
10195327273552Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KDD2023-06-13
10195327277680Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KDD2023-06-13
10195327278243Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KDD2023-06-13
10195327278816Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KDD2023-06-13
10195327279110Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KDD2023-06-13
10195327285029Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KDD2023-06-13
10195327285616Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KDD2023-06-13
10195327286040Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KDD2023-06-13
10195327286415Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KDD2023-06-13
10195327287443Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KDD2023-06-13
10195327287788Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KDD2023-06-13
10193489447897Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KDD2023-06-08
10195327264192Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KDD2023-06-08
10195327265762Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KDD2023-06-08
10195327266646Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KDD2023-06-08
10195327266271Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KDD2023-03-05
10195327271633Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KDD2022-12-18
10195327242763Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KDD2022-11-23
10195327244835Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KDD2022-11-23