FDA.reportPublic FDA data

ELMED INCORPORATED

Primary DI
00198506017568
Brand
ELMED INCORPORATED
Company
ELMED INCORPORATED
Model
ST515300
Catalog number
ST515300
Device description
Simpson Obstetrical Forceps, Overall Length 14”
Published
2024-10-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HCZForceps, Surgical, Gynecological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HCZForceps, Surgical, GynecologicalObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00198506017568PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00198506017568001985060175681985060175680198506017568

GMDN Terms#

Term, Definition table
TermDefinition
Obstetrical forceps, reusableA scissors-like obstetrical instrument intended specifically to assist the birth of the foetus during difficult vaginal births. It typically is designed with two curved blades are that are introduced separately and then connected to a handle to exert traction on the foetal head or to rotate the foetal head in order to facilitate its passage through the birth canal. It is made of metal. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
224-353-6446medical@elmed.com

Regulatory Flags#

DUNS number
049290364
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00198506093876ELMED INCORPORATED9840FS-T9840FS-T2026-08-18
00198506093883ELMED INCORPORATED9841FS-T9841FS-T2026-08-18
00198506093890ELMED INCORPORATED9831FS9831FS2026-08-18
00198506093906ELMED INCORPORATED9835FS9835FS2026-08-18
00198506093913ELMED INCORPORATED9843FS-T9843FS-T2026-08-18
00198506093920ELMED INCORPORATED9844FS-T9844FS-T2026-08-18
00198506093937ELMED INCORPORATEDSTE237820STE2378202026-08-18
00198506093944ELMED INCORPORATEDSTE322424ISTE322424I2026-08-18
00198506093951ELMED INCORPORATED31400-12353HD-OLY31400-12353HD-OLY2026-08-18
00198506093968ELMED INCORPORATED9846FS-T9846FS-T2026-08-18
00198506093975ELMED INCORPORATED25657-1025657-102026-08-18
00198506093982ELMED INCORPORATED22-5200-09F22-5200-09F2026-08-18
00198506093999ELMED INCORPORATEDSTE232825STE2328252026-08-18
00198506094002ELMED INCORPORATED24222-3824222-382026-08-18
00198506094019ELMED INCORPORATED9833FS9833FS2026-08-18
00198506094026ELMED INCORPORATED9842FS-T9842FS-T2026-08-18
00198506094033ELMED INCORPORATED9845FS-T9845FS-T2026-08-18
00198506094040ELMED INCORPORATED9837FS9837FS2026-08-18
00198506094057ELMED INCORPORATEDSTE3230124STE32301242026-08-18
00198506094064ELMED INCORPORATEDSTE6181010STE61810102026-08-18

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776405847MillenniumAvalign Technologies, Inc.HCZ2026-07-26
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00840343727567Gen2SURGIX MEDICAL LLCHCZ2026-04-23
00810123209972Adler Instrument CompanyAdler, Inc.HCZ2026-03-03
00198506088834ELMED INCORPORATEDELMED INCORPORATEDHCZ2026-02-25
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00198506065453ELMED INCORPORATEDELMED INCORPORATEDHCZ2024-10-16
00198506065613ELMED INCORPORATEDELMED INCORPORATEDHCZ2024-10-16
00198506065620ELMED INCORPORATEDELMED INCORPORATEDHCZ2024-10-16
00198506065811ELMED INCORPORATEDELMED INCORPORATEDHCZ2024-10-16
00840343723408GEN2SURGIX MEDICAL LLCHCZ2024-09-18
00840343723699GEN2SURGIX MEDICAL LLCHCZ2024-09-18