FDA.reportPublic FDA data

BALLARD™

Primary DI
10889483563441
Brand
BALLARD™
Company
SUNMED, LLC
Model
140
Catalog number
140
Device description
BALLARD™ MINI-BAL PREP PACK WITH SPECIMEN TRAP
Published
2026-01-12
Public version status
New
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
MMOTray, Surgical, Ent

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MMOTray, Surgical, EntEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30889483563445PackageGS120In Commercial Distribution
00609038123936PreviousGS10
10889483563441PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3088948356344530889483563445
00609038123936006090381239366090381239360609038123936
1088948356344110889483563441

GMDN Terms#

Term, Definition table
TermDefinition
General surgical procedure kit, non-medicated, single-useA typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, but that does not contain pharmaceuticals, intended to be used during: 1) open abdominal surgery; 2) a range of open surgical procedures across multiple clinical specialties (non-dedicated); 3) non-orthopaedic trauma surgery; 4) minor dermatological surgery; or 5) cosmetic surgery below the head. As a kit that includes procedural devices, it is neither dedicated to surgical scrubbing, surgical patient preparation, nor anaesthesia, and is not a dedicated biopsy kit. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
1-800-433-2797info@sun-med.com

Regulatory Flags#

DUNS number
069009268
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10889483564288BALLARD™22103-522103-52025-11-20
10889483564394BALLARD™22113-522113-52025-11-21
10889483564608BALLARD™227101322710132025-11-24
10889483564646BALLARD™22712183227121832025-11-24
10889483564806BALLARD™2271603-52271603-52025-11-21
10889483564813BALLARD™22716036-522716036-52025-11-21
10889483564905BALLARD™227166-5227166-52025-11-21
10889483564936BALLARD™2276-52276-52025-11-21
10889483567005BALLARD™2271652271652025-11-24
10889483623411BALLARD™22056-522056-52025-11-20
10889483623541BALLARD™2271516-52271516-52025-11-21
10889483562611BALLARD™227-5227-52025-11-21
10889483564370BALLARD™22108-522108-52025-11-21
10889483564424BALLARD™2255-52255-52025-11-21
10889483564479BALLARD™2260-52260-52025-11-21
10889483564486BALLARD™22606-522606-52025-11-21
10889483564554BALLARD™22703-522703-52025-11-21
10889483564578BALLARD™227036-5227036-52025-11-21
10889483564691BALLARD™227135-5227135-52025-11-21
10889483564875BALLARD™227161863-5227161863-52025-11-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
14250368861734Tray TTP-VARIACHeinz Kurz GmbHMMO2026-05-21
14250368861741Tray KURZ MeterHeinz Kurz GmbHMMO2026-05-21
14250368861765Tray Cartilage PunchHeinz Kurz GmbHMMO2026-05-21
00757770403929Bausch + LombBausch & Lomb IncorporatedMMO2026-04-30
04250676747204Tray set with flex band and pier pinSpiggle & Theis Medizintechnik GmbHMMO2025-12-03
04250676747211Tray set with flex bandSpiggle & Theis Medizintechnik GmbHMMO2025-12-03
04250676747235Filter modul with 8 x LMSpiggle & Theis Medizintechnik GmbHMMO2025-12-03
04250676747228Tray setSpiggle & Theis Medizintechnik GmbHMMO2025-12-03
04251993600128Filter modul with 8 x LMSpiggle & Theis Medizintechnik GmbHMMO2025-12-03
04251993601927Tray set with flex band and pier pinSpiggle & Theis Medizintechnik GmbHMMO2025-12-03
04251993601934Tray set with flex bandSpiggle & Theis Medizintechnik GmbHMMO2025-12-03
00840217910033Ace Medical CompanyEbner Medical, LLCMMO2025-10-08
00840217910040Ace Medical CompanyEbner Medical, LLCMMO2025-10-08
00840217910057Ace Medical CompanyEbner Medical, LLCMMO2025-10-08
04250676741554Endoscope container with lidSpiggle & Theis Medizintechnik GmbHMMO2025-09-19
04250676741561Endoscope container with lidSpiggle & Theis Medizintechnik GmbHMMO2025-09-19
04250676741578Endoscope container with lidSpiggle & Theis Medizintechnik GmbHMMO2025-09-19
04250676741585Endoscope container with lidSpiggle & Theis Medizintechnik GmbHMMO2025-09-19
04250676741592Endoscope container with lidSpiggle & Theis Medizintechnik GmbHMMO2025-09-19
04250676741608Endoscope container with lidSpiggle & Theis Medizintechnik GmbHMMO2025-09-19
04250676741622Endoscope container with lidSpiggle & Theis Medizintechnik GmbHMMO2025-09-19
04250676741639Endoscope container with lidSpiggle & Theis Medizintechnik GmbHMMO2025-09-19
04250676741899Endoscope container with lidSpiggle & Theis Medizintechnik GmbHMMO2025-09-19
04250407778262FENTEXFENTEX medical GmbHMMO2025-02-19
00840217909396Ace Medical CompanyEbner Medical, LLCMMO2024-12-11
00840217909402Ace Medical CompanyEbner Medical, LLCMMO2024-12-11
10198459084775Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MMO2024-08-04
40198459084776Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MMO2024-08-04
00848253002347InHealth Technologies; Blom-SingerFreudenberg Medical, LLCMMO2023-11-03
00848253002354InHealth Technologies; Blom-Singer®Freudenberg Medical, LLCMMO2023-11-03