FDA.reportPublic FDA data

Sterling Medical Products

Primary DI
10685404001036
Brand
Sterling Medical Products
Company
APOLLO MEDICAL PRODUCTS CORP.
Model
N1197
Device description
COTTON BALLS
Published
2019-07-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Contact Domains#

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10685404001036PackageGS1100In Commercial Distribution
00685404001039PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1068540400103610685404001036
00685404001039006854040010396854040010390685404001039

GMDN Terms#

Term, Definition table
TermDefinition
Cotton wool ball, sterileA sterile, non-dedicated device designed as an absorbent, spherical mass of cotton or man-made fibres intended for use to absorb fluids, typically in a surgical setting. It may be radiopaque to make it visible on x-ray, and may have an attached cord to improve traceability in a surgical setting. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
815-537-5303andrea@sterlingmedproducts.com

Regulatory Flags#

DUNS number
116768422
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
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
00685404001084Sterling Medical Products N1752019-08-02
00685404002951Sterling Medical Products5332024-05-13
00685404001619Sterling Medical Products81082019-09-27
00685404001626Sterling Medical Products81102019-09-27
00685404001633Sterling Medical Products81112019-09-27
00685404001640Sterling Medical Products81192019-09-27
00685404001657Sterling Medical Products81202019-09-27
00685404001664Sterling Medical Products81232019-09-27
00685404001671Sterling Medical Products81282019-09-27
00685404001688Sterling Medical Products81292019-09-27
00685404001695Sterling Medical Products19542019-09-27
00685404001701Sterling Medical Products67052019-09-27
00685404001718Sterling Medical Products73452019-09-27
00685404001725Sterling Medical Products97432019-09-27
00685404001879Sterling Medical Products81212019-09-27
00685404001886Sterling Medical Products81222019-09-27
00685404002746Sterling Medical ProductsR322023-09-23
00685404002753Sterling Medical ProductsS322023-09-23
00685404002760Sterling Medical ProductsR452023-09-23
00685404002777Sterling Medical ProductsS452023-09-23